Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trivalent Influenza Vaccine 1 SP Shz TIV1 · 1 trial · 1 indication
Geometric mean titers will be assessed by a hemagglutination (HAI) method
Influenza antibodies will be assessed using the HAI method.
Geometric mean titers will be assessed by a HAI method
Influenza antibodies will be assessed using the HAI method.
Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination
Injection site reactions: injection site tenderness/pain, erythema, swelling, induration, and ecchymosis. Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability for toddlers aged \<= 23 months and fever, headache, malaise, myalgia and shivering for participants aged \> 2 years.
Adverse events other than solicited reactions
Serious adverse events (including adverse event of special interest) are assessed throughout the study.
| Arm | Type | Description |
|---|---|---|
| Group A: 6 to 35 months, previously unvaccinated, step 1 | EXPERIMENTAL | Participants will receive two injections of SP Shz QIV 0.5 mL at Day 0 and Day 28 |
| Group 1: 6 to 35 months, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.25 mL or SP Shz QIV 0.5 mL at Day 0 or SP Shz TIV1 0.25 mL or SP Shz TIV2 0.25 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| Group 2: 3 to 8 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| Group 3: 9 to 17 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Group 4: 18 to 60 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Group 5: >=61 years | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
| Trivalent Influenza Vaccine 1 SP Shz TIV1 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
| Trivalent Influenza Vaccine 2 SP Shz TIV2 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
Inclusion criteria : * Aged ≥ 6 months on the day of the first study visit/inclusion * In good health or with underlying medical condition(s) that are judged to be stable by the investigator. Medically-stable is defined as: * No new diagnosis OR * No new class of prescription drug initiated du...